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  Regulatory Submissions  
Regulatory Submissions
  1. CMC Section Development
  2. 505 (b)(2) Submissions (NDA)
  3. Orphan Drug Submissions (NDA)
  4. Suitability Petitions (ANDA)
  5. Paragraph IV
  6. NDA and ANDA Submissions
  7. Pre-IND and Pre-NDA meetings with FDA
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